The following data is part of a premarket notification filed by Atlantic Antibodies with the FDA for Spq(tm) Test System For Apolipoprotein Al.
| Device ID | K870862 |
| 510k Number | K870862 |
| Device Name: | SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL |
| Classification | Apolipoproteins |
| Applicant | ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough, ME 04074 |
| Contact | Thomas Jordan |
| Correspondent | Thomas Jordan ATLANTIC ANTIBODIES 10 NONESUCH RD. P.O. BOX 60 Scarborough, ME 04074 |
| Product Code | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-03-24 |